Asthma in ChildrenSNPNCT06840717
Association Between Genetic Polymorphisms and Type 2 Asthma in Children
An observational study of Asthma in Children and Genetic Disease, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
To further understand the role of gene single nucleotide polymorphism (SNP) in the occurrence of type 2 inflammation-related asthma in children by analyzing the gene single nucleotide polymorphism (SNP), lung function and type 2 inflammation indicators of children diagnosed with asthma in outpatient and inpatient. Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Genetic Disease, Inflammation
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2024to 30 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with asthma, aged 3-14 years, attending our hospital.
Who may be able to join
- All children with asthma diagnosis accord with the GINA in 2023 edition;
- Other diseases that could cause wheezing and cough were excluded, such as acute laryngitis, diphtheria, congenital airway abnormalities, and tracheal foreign bodies;
- In front of the hospital 2 weeks without antibiotics, systemic hormone medication history;
- There were no other complications, such as congenital heart disease, pneumonia, gastroesophageal reflux disease, muscle dysplasia, etc.
Who cannot join
- Children who had taken immunosuppressants, antibiotics and other drugs for a long time before admission;
- Children with primary immunodeficiency disease;
- The children and their families failed to cooperate or refused the experimental observation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, 510120
Lihong Sun, master, +86-13719240285, sunlihong9797@126.com
About this study
Official title: Association Between Cytokines Gene Single Nucleotide Polymorphisms and Type 2 Inflammatory Asthma in Children
To further understand the role of gene single nucleotide polymorphism (SNP) in the occurrence of type 2 inflammation-related asthma in children by analyzing the gene single nucleotide polymorphism (SNP), lung function and type 2 inflammation indicators of children diagnosed with asthma in outpatient and inpatient. To provide a theoretical basis for the study of personalized treatment and prevention strategies for asthma.
Read the detailed description
Type of study:
This was a prospective, randomized case-control design.To investigate the role of genetic single nucleotide polymorphisms (SNPs) in children with type 2 asthma, and the effects of SNPs on type 2 inflammatory markers and pulmonary function indicators.
Methods:
Children with asthma who were treated at our pediatric respiratory specialty clinic and who met the criteria for type 2 inflammation were included in the case group (Type 2 inflammation was considered to be present if any of the following conditions were present: Fraction of exhaled nitric oxide(FeNO)≥20ppb；Blood eosinophilcount≥350/ul；Percentage of sputum eosinophils>3%; Asthma is caused by inhaled allergens.). The control group is healthy children who underwent physical examination. To compare the differences of single nucleotide polymorphisms (SNPs) between children with type 2 asthma and healthy children, and to explore the risk factors of type 2 asthma.
The differences of indicators between different genotypes were compared, including type 2 inflammation indicators (including Fraction of exhaled nitric oxide(FeNO)、Blood eosinophil count、Percentage of sputum eosinophils and Serum total immunoglobulin E) and pulmonary function indicators(Forced expiratory volume in one second(FEV1)、Forced vital capacity(FVC)、Ratio of forced expiratory volume in one second to forced vital capacity(FEV1/FVC) and Peak expiratory flow(PEF)).
- Conditions
- Asthma in Children, Genetic Disease, Inflammation
- Keywords
- cytokines, Single nucleotide polymorphism, type 2 inflammation, ashtma, Susceptibility
- Medical subject headings
- Genetic Diseases, Inborn, Inflammation, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Diagnosis of asthma children | |
| Control group | Physical health of children |
What is being measured
The primary outcome is the main question the study is designed to answer.
type 2 inflammation indicators
Fraction of exhaled nitric oxide(FeNO)、Blood eosinophil count、Percentage of sputum eosinophils and Serum total immunoglobulin E
Measured: Outpatient visits for the first time
pulmonary function indicators
Forced expiratory volume in one second(FEV1)、Forced vital capacity(FVC)、Ratio of forced expiratory volume in one second to forced vital capacity(FEV1/FVC) and Peak expiratory flow(PEF)
Measured: Outpatient visits for the first time
single nucleotide polymorphism
Differences in SNPs of genes detected in children's blood samples
Measured: Outpatient visits for the first time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start30 Jan 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI-HONG SUN, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840717
- Sponsor's protocol ID
- GuangzhouIRD-CLY
- Acronym
- SNP
- Status last verified
- Feb 2025
- First submitted
- 3 Oct 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Cytokines Gene Single Nucleotide Polymorphisms and Type 2 Inflammatory Asthma in Children
- ClinicalTrials.gov ID
- NCT06840717
- Acronym / sponsor ID
- SNP / GuangzhouIRD-CLY
- Conditions
- Asthma in Children, Genetic Disease, Inflammation
- Keywords
- cytokines, Single nucleotide polymorphism, type 2 inflammation, ashtma, Susceptibility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To further understand the role of gene single nucleotide polymorphism (SNP) in the occurrence of type 2 inflammation-related asthma in children by analyzing the gene single nucleotide polymorphism (SNP), lung function and type 2 inflammation indicators of children diagnosed with asthma in outpatient and inpatient. To provide a theoretical basis for the study of personalized treatment and prevention strategies for asthma.
Detailed description
Type of study:
This was a prospective, randomized case-control design.To investigate the role of genetic single nucleotide polymorphisms (SNPs) in children with type 2 asthma, and the effects of SNPs on type 2 inflammatory markers and pulmonary function indicators.
Methods:
Children with asthma who were treated at our pediatric respiratory specialty clinic and who met the criteria for type 2 inflammation were included in the case group (Type 2 inflammation was considered to be present if any of the following conditions were present: Fraction of exhaled nitric oxide(FeNO)≥20ppb；Blood eosinophilcount≥350/ul；Percentage of sputum eosinophils>3%; Asthma is caused by inhaled allergens.). The control group is healthy children who underwent physical examination. To compare the differences of single nucleotide polymorphisms (SNPs) between children with type 2 asthma and healthy children, and to explore the risk factors of type 2 asthma.
The differences of indicators between different genotypes were compared, including type 2 inflammation indicators (including Fraction of exhaled nitric oxide(FeNO)、Blood eosinophil count、Percentage of sputum eosinophils and Serum total immunoglobulin E) and pulmonary function indicators(Forced expiratory volume in one second(FEV1)、Forced vital capacity(FVC)、Ratio of forced expiratory volume in one second to forced vital capacity(FEV1/FVC) and Peak expiratory flow(PEF)).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | –Diagnosis of asthma children |
| Control group | – | –Physical health of children |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with asthma, aged 3-14 years, attending our hospital.
Key inclusion criteria (4 listed)
- All children with asthma diagnosis accord with the GINA in 2023 edition;
- Other diseases that could cause wheezing and cough were excluded, such as acute laryngitis, diphtheria, congenital airway abnormalities, and tracheal foreign bodies;
- In front of the hospital 2 weeks without antibiotics, systemic hormone medication history;
- There were no other complications, such as congenital heart disease, pneumonia, gastroesophageal reflux disease, muscle dysplasia, etc.
Key exclusion criteria (3 listed)
- Children who had taken immunosuppressants, antibiotics and other drugs for a long time before admission;
- Children with primary immunodeficiency disease;
- The children and their families failed to cooperate or refused the experimental observation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
type 2 inflammation indicators
Time frame: Outpatient visits for the first time
Fraction of exhaled nitric oxide(FeNO)、Blood eosinophil count、Percentage of sputum eosinophils and Serum total immunoglobulin E
pulmonary function indicators
Time frame: Outpatient visits for the first time
Forced expiratory volume in one second(FEV1)、Forced vital capacity(FVC)、Ratio of forced expiratory volume in one second to forced vital capacity(FEV1/FVC) and Peak expiratory flow(PEF)
single nucleotide polymorphism
Time frame: Outpatient visits for the first time
Differences in SNPs of genes detected in children's blood samples
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children and Genetic Disease, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lihong Sun, M.D. (13719240285, sunlihong9797@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type 2 inflammation indicators (time frame: Outpatient visits for the first time). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.